Zelnorm Recall
Zelnorm Recall Timeline
2000—Lotronex and Propulsid, a pair of drugs that manipulate serotonin in the digestive system, are removed from the market. The former is found to cause life-threatening constipation, and the latter can cause heart problems.
June 18, 2001—A “not approvable” letter about Zelnorm (made by Novartis of Switzerland) is issued by the Food and Drug Administration.
July 2002—The FDA approves Zelnorm for the short-term treatment of irritable bowel syndrome (IBD) in women under the age of 65.
2003—Novartis begins airing television ads for Zelnorm in which beautiful young women pull up their shirts to reveal writing on their bellies. Zelnorm sales rise accordingly.
April 28, 2004—The FDA calls for new labeling about Zelnorm side effects, specifically warnings about diarrhea and ischemic colitis. The agency attributes several Zelnorm deaths to these conditions.
August 2004—Two years after Zelnorm went on the market, the FDA expands its patient base. It can now be prescribed (1) for men, (2) to treat chronic constipation and (3) for people older than 65.
April 29, 2005—For the second time, the FDA issues a label update to warn patients about the side effects of Zelnorm. The changes were made after patients experienced diarrhea both during clinical trials and marketed use; some cases require hospitalization because of Zelnorm side effects.
December 2005—Zelnorm is turned down by the European Medicines Agency as a treatment for IBD; it will reiterate that stance four months later.
2005—Prescriptions written for Zelnorm in the U.S. top 2 million.
Late 2006—Swiss government officials ask Novartis to perform a routine safety review of Zelnorm. The company analyzes its clinical trial data and finds that people taking the drug are eight times more likely to suffer Zelnorm heart attacks or strokes than those taking placebo.
February 2007—The FDA receives Novartis’ findings on the side effects of Zelnorm.
March 28, 2007—The FDA investigates and asks Novartis to issue a Zelnorm withdrawal because of its risk of Zelnorm side effects—specifically its tendency to create heart problems.
March 30, 2007—Reluctantly, Novartis goes along with the FDA’s request, ending all marketing and sales of Zelnorm. The FDA states that Novartis will issue a full Zelnorm recall in the future.
